Italian Validation of the Forgotten Joint Score(Fjs 2015)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Validating the Forgotten Joint Score.
研究概览
简要总结
This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS)
详细描述
This is an observational, prospective study that has the primary goal of validating the Forgotten Joint Score (FJS) as described by Behrend and Giesinger in 2012. Patients will be given two self-assessment questionnaires (WOMAC and FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery.
Comparison of data will be done for each patient by evaluating the evolution of the postoperative period, comparing the results obtained with a well known validated score (WOMAC).
Questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Age range between 55 and 85 years
- •Italian mother-tongue
- •Patients with unilateral gonarthrosis who need total knee prosthesis
排除标准
- •Patients with orthopedic pathologies of other origin
- •Patients with history of previous articular prosthetic replacement surgery on joints of the lower limb.
- •Patients with history of previous major cardiovascular events
- •Patients who need aids for walking
- •Patients claiming that they can not submit to follow-up and therefore can not complete the study
结局指标
主要结局
Validating the Forgotten Joint Score.
时间窗: 18 month
Patients will be given self-assessment questionnaires Forgotten Joint Score (FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery. FJS: minimum score 0 (worse outcome); maximum 100 (better outcome)
次要结局
- BMI(18 months)